BLASOLUTIONINJECTIONPriority Review
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
6/8 — Strong
Priority Review
ENFLONSIA (clesrovimab) by Merck & Co. is fusion protein inhibitors [moa]. Approved for respiratory syncytial virus anti-f protein monoclonal antibody [epc]. First approved in 2025.
Drug data last refreshed 5h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENFLONSIA (clesrovimab) is a monoclonal antibody targeting the F protein of respiratory syncytial virus (RSV), approved by the FDA in June 2025. It functions as a fusion protein inhibitor to prevent RSV infection. The drug is administered as an injection solution and represents a key therapeutic option in the growing RSV immunization market.
Launch
Early-stage launch product with moderate competitive pressure (30%) indicates significant commercial potential but requires aggressive market penetration strategy and team expansion.
Mechanism of Action
Fusion Protein Inhibitors
Pharmacologic Class:
Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Started Nov 2021
1,003 enrolled
RSV Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
Started Apr 2021
3,632 enrolled
Respiratory Syncytial Virus Infection
Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)
Started Oct 2019
80 enrolled
Respiratory Syncytial Viruses
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
Started Sep 2018
183 enrolled
Respiratory Tract InfectionRespiratory Syncytial Virus
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.